DURIDE Isosorbide mononitrate 60mg tablet blister pack

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

isosorbide mononitrate, Quantity: 60 mg

から入手可能:

Alphapharm Pty Ltd

医薬品形態:

Tablet, modified release

構図:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; aluminium silicate; colloidal anhydrous silica; hard paraffin; synthetic paraffin; titanium dioxide; lactose monohydrate; hypromellose; iron oxide yellow; iron oxide red; macrogol 4000; iron oxide black

投与経路:

Oral

パッケージ内のユニット:

30

処方タイプ:

(S4) Prescription Only Medicine

適応症:

Duride is indicated for the prophylactic treatment of angina pectoris. Duride is not recommended for the management of acute attacks of angina pectoris (see section 4.4 Special Warnings and Precautions for Use).

製品概要:

Visual Identification: yellow, film coated, elliptical shaped tablet, 13. 1 x 7.1mm, scored on both sides and imprinted "IM I 60" on one side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

認証ステータス:

Registered

承認日:

1997-10-21

情報リーフレット

DURIDE
®
D
U
R
I
D
E
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING DURIDE?
DURIDE contains the active ingredient isosorbide mononitrate. DURIDE
is used to prevent angina.
For more information, see Section 1. Why am I using DURIDE? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE DURIDE?
Do not use if you have ever had an allergic reaction to DURIDE or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
DURIDE? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with DURIDE and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE DURIDE?
•
Your doctor will decide the right dose for you.
•
The usual dose is one tablet once a day.
More instructions can be found in Section 4. How do I use DURIDE? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING DURIDE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
DURIDE.
•
If you become pregnant while taking this medicine, tell your doctor
immediately.
•
Keep all of your doctor's appointments so that your progress can be
checked.
•
If you continue to have angina attacks, or if they become frequent
while you are taking DURIDE tell your
doctor.
THINGS YOU
SHOULD NOT DO
•
Do not use DURIDE to relieve acute attacks of angina.
•
Do not take DURIDE to treat any other complaints unless your doctor
tells you to.
•
Do not stop taking your medicine, or change the dose, without checking
with your doctor.
DRIVING
OR USING
MACHINES
•
Be careful driving or operating machinery until you know how DURIDE
affects you.
DRINKING
ALCOHOL
•
Be careful when

製品の特徴

AUSTRALIAN PRODUCT INFORMATION
DURIDE
®
_isosorbide mononitrate modified-release tablet _
1
NAME OF THE MEDICINE
Isosorbide mononitrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified-release tablet contains 60 mg of isosorbide mononitrate
as the active ingredient.
Excipients of known effect: lactose and sulfites.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
DURIDE tablets are yellow, film coated, elliptical shaped tablet, 13.1
x 7.1mm, scored on both sides and
imprinted "IM I 60" on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DURIDE is indicated for the prophylactic treatment of angina pectoris.
DURIDE is not recommended for the management of acute attacks of
angina pectoris (see section 4.4 SPECIAL
WARNINGS AND PRECAUTIONS FOR USE).
4.2
DOSE AND METHOD OF ADMINISTRATION
One 60 mg tablet once daily. The dose may be increased to 120 mg once
daily. Both tablets should be taken at
the same time.
DURIDE should not be administered twice daily.
If headache occurs, the initial dose may be reduced to half a tablet
once a day until the headache disappears.
Patients with severe renal impairment may require dosage reduction to
half a tablet given once daily.
DURIDE TABLETS SHOULD BE SWALLOWED WHOLE WITH HALF A GLASS OF FLUID.
THE TABLETS SHOULD NOT BE CRUSHED OR CHEWED.
Half tablet doses may be administered without affecting the
modified-release properties of DURIDE, if care is
taken not to crush or chew the tablets.
4.3
CONTRAINDICATIONS
Known hypersensitivity to nitrates or to any of the ingredients in
DURIDE.
Shock (including cardiogenic shock), hypotension, obstructive
hypertrophic cardiomyopathy and pericarditis.
Phosphodiesterase type 5 inhibitors (e.g. sildenafil, tadalafil and
vardenafil) must not be given concomitantly
with DURIDE.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
PLEASE NOTE:
There is a risk of developing tolerance to haemodynamic and
antianginal effects if higher doses (more than 120
mg/day) and/or more frequent doses (e.g. twic